Page 8: Health Canada – 2014–2015 – Supplementary Information Tables – Departmental Performance Report - User Fees, Regulatory Charges and External Fees

User Fees, Regulatory Charges and External Fees

Reporting on User Fees Act

Fee name: Fee Rights to Sell Drugs Fee

Fee type

Regulatory (R)

Fee-setting authority

Financial Administration Act)

Year introduced

1995)

Year last amended

2011)

Performance standard

120 Calendar days to update the Drug Product Database following notification)

Performance results

100% within 120 calendar days)

Other information

N/A

Financial Information, 2014-15 (dollars)
Forecast revenue Actual revenue Full cost
11,643,706 11,605,658 59,181,253
Financial Information, 2015-16, 2016-17 and 2017-18 (dollars)
Planning year Forecast revenue Estimated full cost
2015-16 11,769,634 60,237,147
2016-17 12,009,241 60,027,541
2017-18 12,249,426 61,195,150

Fee name: Drug Establishment Licensing Fees

Fee type

Regulatory (R))

Fee-setting authority

Financial Administrative Act)

Year introduced

1998)

Year last amended

2011)

Performance standard

250 Calendar days to issue / renew license)

Performance results

Average number of days: 74 days)

Other information

N/A

Financial Information, 2014-15 (dollars)
Forecast revenue Actual revenue Full cost
11,803,459 14,611,643 22,886,144
Financial Information, 2015-16, 2016-17 and 2017-18 (dollars)
Planning year Forecast revenue Estimated full cost
2015-16 13,817,312 21,861,686
2016-17 14,093,658 23,434,550
2017-18 14,375,531 23,878,347

Fee name: Drug Submission Evaluation Fees (Pharmaceuticals and Biologic Products)

Fee type

Regulatory (R))

Fee-setting authority

Financial Administration Act)

Year introduced

1995)

Year last amended

2011)

Performance standard

Review 1 = Drug Submission Review (average time in calendar days).

Pharmaceuticals

  • NAS: NDS = 300
  • CLIN C&M: NDS = 300
  • CLIN C&M: SNDS = 300
  • CLIN : NDS = 300
  • CLIN: SNDS = 300
  • CLIN: DIN A = 210
  • COMP C&M: ANDS = 180
  • COMP C&M: NDS = 180
  • COMP C&M: SANDS = 180
  • COMP C&M: SNDS = 180
  • COMP C&M: DIN A = 210
  • C&M: ANDS = 180
  • C&M: NDS = 180
  • C&M: SANDS = 180
  • C&M: SNDS = 180
  • C&M: DIN A = 210
  • PUBLISHED DATA: SNDS = 300
  • PUBLISHED DATA: DIN A = 210
  • Rx to OTC Switch: SNDS = 180
  • DISINFECTANT: NDS-D = 300
  • DISINFECTANT: SNDS-D = 300
  • DISINFECTANT: DIN D = 210
  • DISINFECTANT: DIN D = 180
  • LABELLING ONLY: NDS = 60
  • LABELLING ONLY: SNDS = 60
  • LABELLING ONLY: ANDS = 60
  • LABELLING ONLY: SANDS = 60
  • LABELLING ONLY: DIN A = 180
  • LABEL STANDARD: DIN A = 45
  • LABEL STANDARD: DIN D = 45
  • LABEL STANDARD: DIN F = 45
  • ADMINISTRATIVE: ANDS = 45
  • ADMINISTRATIVE: NDS = 45
  • ADMINISTRATIVE: SNDS = 45
  • ADMINISTRATIVE: SANDS = 45
  • ADMINISTRATIVE: DIN A = 45
  • ADMINISTRATIVE: DIN D = 45

Biologics

  • NAS: NDS = 300
  • CLIN C&M: NDS = 300
  • CLIN C&M: SNDS = 300
  • CLIN C&M: DIN B = 210
  • CLIN: NDS = 300
  • CLIN: SNDS = 300
  • C&M: ANDS = 180
  • C&M: SANDS = 180
  • C&M: SNDS = 180
  • C&M: DINB = 210
  • COMP C&M: ANDS = 180
  • COMP C&M: SNDS = 180
  • LABELLING ONLY: SNDS = 60
  • PUBLISHED DATA: SNDS = 300
  • ADMINISTRATIVE: NDS = 45
  • ADMINISTRATIVE: DINB = 45
Performance results

Review 1 = Drug Submission Review (average time in calendar days)

Pharmaceuticals

  • NAS: NDS = 257
  • CLIN C&M: NDS = 278
  • CLIN C&M: SNDS = 280
  • CLIN: NDS = N/A
  • CLIN: SNDS = 257
  • CLIN: DIN A = 208
  • COMP C&M: ANDS = 171
  • COMP C&M: NDS = 167
  • COMP C&M: SANDS = 168
  • COMP C&M: SNDS = 155
  • COMP C&M: DIN A = 178
  • C&M: ANDS = 173
  • C&M: NDS = 161
  • C&M: SANDS = 151
  • C&M: SNDS = 161
  • C&M: DIN A = 168
  • PUBLISHED DATA: SNDS = 230
  • PUBLISHED DATA: DIN A = N/A
  • Rx to OTC Switch: SNDS = 161
  • DISINFECTANT: NDS-D = 299
  • DISINFECTANT: SNDS-D = N/A
  • DISINFECTANT: DIN D = 196
  • DISINFECTANT: DIN D = N/A
  • LABELLING ONLY : NDS = 52
  • LABELLING ONLY : SNDS = 51
  • LABELLING ONLY : ANDS = 47
  • LABELLING ONLY : SANDS = 33
  • LABELLING ONLY : DIN A = 159
  • LABEL STANDARD: DIN A = 32
  • LABEL STANDARD: DIN D = 39
  • LABEL STANDARD: DIN F = 24
  • ADMINISTRATIVE: ANDS = 34
  • ADMINISTRATIVE: NDS = 33
  • ADMINISTRATIVE: SNDS = 25
  • ADMINISTRATIVE: SANDS = 32
  • ADMINISTRATIVE: DIN A = 13
  • ADMINISTRATIVE: DIN D = 33

Biologics

  • NAS: NDS = 270
  • CLIN C&M: NDS = 268
  • CLIN C&M: SNDS = 289
  • CLIN C&M: DIN B = 210
  • CLIN: NDS = N/A
  • CLIN: SNDS = 268
  • C&M ANDS = 180
  • C&M: SANDS = 180
  • C&M: SNDS = 160
  • C&M: DINB = 210
  • COMP C&M: ANDS = 178
  • COMP C&M: SNDS = 188
  • LABELLING ONLY: SNDS = 51
  • PUBLISHED DATA: SNDS = 242
  • ADMINISTRATIVE: NDS = 40
  • ADMINISTRATIVE: DINB = 45
Other information

Review 1 = the period from the date of acceptance for review to the first issuance of a decision)

  1. Acronyms
    NDS
    New Drug Submission
    SNDS
    Supplement to a New Drug Submission
    ANDS
    Abbreviated New Drug Submission
    SANDS
    Supplement to an Abbreviated New Drug Submission
    DIN
    Drug Identification Number
    • DIN A drug identification number application for a pharmaceutical
    • DIN B drug identification number application for a biological
    • DIN D drug identification number application for a disinfectant
    • DIN F drug identification number application for a Category IV Monograph
    INDS
    Investigational New Drug Submission
    ESC
    Experimental Studies Certificate
    NC
    Notifiable Change
    NAS
    New Active Substance
    OTC
    Over the Counter
    Rx
    Prescription
    CLIN
    Clinical
    COMP
    Comparative Bio, Clinical or Pharmacodynamics Studies
    C&M
    Chemistry and Manufacturing
    N/A
    At time of reporting either no submissions of that type were received or no reviews of that submission type were completed, therefore no performance information available.
  2. Performance

    As per the User Fee Act (UFA), when a regulating authority's performance in a particular fiscal year in respect of a user fee does not meet the standards established by it for that fiscal year by a percentage greater than 10%, the UFA requires that the user fee be reduced by the percentage missed, up to a maximum of 50%. The reduced fees are in effect until the date of the next Departmental Performance Report.

    One Biologics Drug Evaluation fee line did not meet the performance standard, but did not exceed the target by more than 10%, so there are no penalties incurred. They are: COMPARATIVE STUDIES C&M/ SNDS, with a target of 180 days, and a performance of 188 days.

Financial Information, 2014-15 (dollars)
Forecast revenue Actual revenue Full cost
40,849,268 37,520,688 82,767,940
Financial Information, 2015-16, 2016-17 and 2017-18 (dollars)
Planning year Forecast revenue Estimated full cost
2015-16 42,853,496 85,012,016
2016-17 43,910,844 87,655,008
2017-18 44,789,060 89,388,402

Fee name: Medical Device License Application Fees

Fee type

Regulatory (R))

Fee-setting authority

Financial Administrative Act)

Year introduced

1998)

Year last amended

2011)

Performance standard

Review 1 = Drug Submission Review (average time in calendar days)

  • Class II New = 15
  • Class III New = 60
  • Class III Near Patient = 60
  • Class III Manufacturing Amendment = 60
  • Class III Significant Amendment = 60
  • Class IV New = 75
  • Class IV Human-Animal Tissue = 75
  • Class IV Manufacturing Amendment = 75
  • Class IV Significant Amendment = 75
Performance results

Review 1 = Drug Submission Review (average time in calendar days)

  • Class II New = 9
  • Class III New = 55
  • Class III Near Patient = 53
  • Class III Manufacturing Amendment = 50
  • Class III Significant Amendment = 54
  • Class IV New = 70
  • Class IV Human-Animal Tissue = 45
  • Class IV Manufacturing Amendment = 54
  • Class IV Significant Amendment = 64
Other information

Review 1 = the period from the date of acceptance for review to the first issuance of a decision

Financial Information, 2014-15 (dollars)
Forecast revenue Actual revenue Full cost
5,967,920 5,900,791 20,495,145
Financial Information, 2015-16, 2016-17 and 2017-18 (dollars)
Planning year Forecast revenue Estimated full cost
2015-16 6,303,279 19,668,612
2016-17 6,430,326 17,812,300
2017-18 6,558,932 18,148,914

Fee name: Fee for Right to Sell a Licensed Medical Device

Fee type

Regulatory (R))

Fee-setting authority

Financial Administrative Act)

Year introduced

1999)

Year last amendedc

2011)

Performance standard

20 calendar days from deadline for receipt of annual notification to update the Medical Devices License Listing (MDALL) database.)

Performance results

100% within 20 calendar days)

Other information

N/A

Financial Information, 2014-15 (dollars)
Forecast revenue Actual revenue Full cost
8,471,469 8,651,245 12,118,279
Financial Information, 2015-16, 2016-17 and 2017-18 (dollars)
Planning year Forecast revenue Estimated full cost
2015-16 8,076,010 12,946,349
2016-17 8,255,977 12,629,451
2017-18 8,421,096 12,879,536

Fee name: Medical Device Establishment Licensing Fees

Fee type

Regulatory (R))

Fee-setting authority

Financial Administration Act)

Year introduced

2000)

Year last amended

2011)

Performance standard

120 Calendar days to issue / renew license)

Performance results

Average number of days: 53 days)

Other information

N/A

Financial Information, 2014-15 (dollars)
Forecast revenue Actual revenue Full cost
9,592,621 9,789,723 10,423,801
Financial Information, 2015-16, 2016-17 and 2017-18 (dollars)
Planning year Forecast revenue Estimated full cost
2015-16 9,052,447 9,653,367
2016-17 9,233,496 10,787,111
2017-18 9,418,166 10,971,608

Fee name: Veterinary Drug Evaluation Fees

Fee type

Regulatory (R))

Fee-setting authority

Financial Administrative Act)

Year introduced

1996)

Year last amended

N/A)

Performance standard

Review 1 (average time in calendar days)

  • NDS (including Priority Review) = 300
  • ANDS = 300
  • SNDS = 240
  • SANDS = 240
  • Admin = 90
  • DIN (including changes to DINs) = 120
  • NC = 90
  • ESC = 60
  • Labels = 45
  • Emergency Drug Release = 2
Performance results

Review 1 (average time in calendar days)

  • NDS (including Priority Review) = 375
  • ANDS = 348
  • SNDS = 214
  • SANDS = N/A
  • Admin = 60
  • DIN (including changes to DINs) = 107
  • NC = 65
  • ESC = 45
  • Labels = N/A
  • Emergency Drug Release = <2 days
Other information

Review 1 = Drug Submission Review

NDS
New Drug Submission
ANDS
Abbreviated New Drug Submission
SNDS
Supplement to a New Drug Submission
SANDS
Supplement to an Abbreviated New Drug Submission
NC
Notifiable Change
ESC
Experimental Studies Certificate
Financial Information, 2014-15 (dollars)
Forecast revenue Actual revenue Full cost
853,401 718,712 8,683,477
Financial Information, 2015-16, 2016-17 and 2017-18 (dollars)
Planning year Forecast revenue Estimated full cost
2015-16 853,401 8,865,549
2016-17 853,401 9,056,764
2017-18 853,401 9,236,315

Fee name: Fees charged for filing a claim for exemption under the Hazardous Materials Information Review Act

Fee type

Regulatory (R))

Fee-setting authority

Hazardous Materials Information Review Act, section 48 and Hazardous Materials Information Review Regulations, sections 4, 5 and 7.)

Year introduced

1988)

Year last amended

2002)

Performance standard

All claims registered within seven days of receipt of the complete application package.)

Performance results

77% of claims were registered within seven days of receipt of the complete application package.)

Other information

Issues specifically related to program transition and the development of new Confidential Business Information (CBI) processes reduced the ability of Workplace Hazardous Material Directorate (WHMD) to maintain its seven-day service standard over the 2014-15 fiscal year.

Financial Information, 2014-15 (dollars)
Forecast revenue Actual revenue Full cost
570,000 413,640 3,234,095
Financial Information, 2015-16, 2016-17 and 2017-18 (dollars)
Planning year Forecast revenue Estimated full cost
2015-16 570,000 3,234,095
2016-17 570,000 3,234,095
2017-18 570,000 3,234,095

Fee name: Pest Control Product Application Examination Service

Fee type

Regulatory (R))

Fee setting authority

Pest Control Products Act (PCPA))

Year introduced

1997)

Year last amended

N/A)

Performance standard

The performance standard is 90% of applications are to be processed within the applicable review timelines.

  • Category A: Review timelines range from 285 to 655 days.
  • Category B: Review timelines range from 158 to 470 days.
  • Category C: Review timeline is 240 days.
  • Category D: Review timelines range from 10 to 247days.
  • Category E: Review timelines range from 30 to 159 days.
Performance results
  • Category A = 97%
  • Category B = 96%
  • Category C = 92%
  • Category D = 94%
  • Category E = 57%
Other Information

N/A

Financial Information, 2014-15 (dollars)
Forecast revenue Actual revenue Full cost
3,490,000 2,760,000 21,202,000
Financial Information, 2015-16, 2016-17 and 2017-18 (dollars)
Planning year Forecast revenue Estimated full cost
2015-16 3,490,000 27,024,000
2016-17 3,490,000 24,552,000
2017-18 3,490,000 24,481,000

Fee name: Right or Privilege to manufacture or sell a Pest Control Product in Canada and for Establishing a Maximum Residue Limit in relation to a Pest Control Product.

Fee type

Regulatory (R))

Fee-setting authority

Financial Administrative Act (FAA))

Year introduced

1997)

Year last amended

N/A)

Performance standard

100% of all fees for the right or privilege to manufacture or sell a pest control product in Canada are invoiced by April 30th of each fiscal year.)

Performance results

100% of all invoices were issued by April 30, 2015.)

Other Information

N/A

Financial Information, 2014-15 (dollars)
Forecast revenue Actual revenue Full cost
4,500,000 5,229,000 40,163,000
Financial Information, 2015-16, 2016-17 and 2017-18 (dollars)
Planning year Forecast revenue Estimated full cost
2015-16 4,500,000 34,845,000
2016-17 4,500,000 31,657,000
2017-18 4,500,000 31,566,000

Fee name: Fees for processing requests filed under the Access to Information Act.

Fee type

Other products and services)

Fee-setting authority

Access to Information Act)

Year introduced

1988)

Year last amended

1992)

Performance standard

A response is provided within 30 days following receipt of a request; the response time may be extended under section 9 of the Access to Information Act.)

Performance results

A response is provided within 30 days following receipt of a request; the response time may be extended under section 9 of the Access to Information Act.)

Other information

Under the Access to Information Act, fees under $25 may be waived when deemed to be in the public interest. Fees waived during 2014-15 for Health Canada was $3,335. Fees waived during 2014-2015 for Public Health Agency of Canada was $1,603.

Includes cases where a Notice of Extension is sent to the requester within 30 days of receipt of the request.

Financial Information, 2014-15 (dollars)
Forecast revenue Actual revenue Full cost
11,000 7,301 7,665,000
Financial Information, 2015-16, 2016-17 and 2017-18 (dollars)
Planning year Forecast revenue Estimated full cost
2015-16 9,000 7,970,000
2016-17 9,000 7,970,000
2017-18 9,000 7,970,000

Summary of Financial Information for All User Fees and Regulatory Charges

Summary of Financial Information for All User Fees and Regulatory Charges, 2014-15 (dollars)
  Forecast revenue Actual revenue Full cost
Regulatory subtotal 97,741,844 97,201,100 281,155,134
Other products and services subtotal 11,000 7,301 7,665,000
Total, all fee types 97,752,844 97,208,401 288,820,134
Health Canada Financial Information, 2015-16, 2016-17 and 2017-18 (dollars)
Planning year Forecast revenue Estimated full cost
2015-16 101,294,579 291,317,821
2016-17 103,355,943 288,815,820
2017-18 105,234,612 292,949,367

Reporting on the Policy on Service Standards for External Fees

General Information by Fee
Fee Name Service standard Performance results Stakeholder consultation in 2014-15 or prior fiscal years

Certificates of Pharmaceutical Product (Drug Export) FeesFootnote *

10 working days to issue certificate

Average number of days: eight Days.

In April 2010, Health Canada's Proposal to update current user fees for regulatory activities related to human drugs and medical devices was tabled in Parliament, as required by the User Fees Act. The Senate Standing Committee on Social Affairs, Science and Technology undertook the review of the proposal, and recommended to the Senate that the proposal be approved with no changes. On May 26, 2010, the Senate adopted the report of its Committee, thereby concluding the Parliamentary review of Health Canada's Proposal.

As user fees are set in regulations, any changes to update them are required to go through the Canada Gazette process. The regulatory proposal was published in the Canada Gazette, Part I on November 13, 2010 for a 75-day consultation period. A summary of stakeholders' comments and Health Canada's responses was published in Canada Gazette, Part II, as part of the Regulatory Impact Analysis Statement that accompanied the regulations. The regulations containing updated user fees came into force on April 1, 2011.

There is an annual 2% increase in regulatory fees along with the updated non-regulatory fees (Drug Master Files and Certificate of Pharmaceutical Products). These increases come into effect April 1st of every year. Notice of the updates is posted in the Canada Gazette annually as per the requirements for updating the fees.

In addition, the Health Canada user fee website was updated to provide notice of the fee updates along with links to the Canada Gazette notice, and a communiqué message was sent to notify industry stakeholders of the updated non-regulatory fees.

In October 2014, Health Canada published the 2014 Review of the Fees in Respect of Drugs and Medical Devices Regulations. This document fulfils Health Canada's commitment to review its fees, costs and operational performance for services every three years and highlights the successes and challenges Health Canada has experienced during the implementation of the user fee regulations.

Drug Establishment Licensing Fees

250 calendar days to issue / renew licence

Average number of days: 74 Days.

Drug Master File FeesFootnote *

30 calendar days

Within 30 calendar days upon receipt of a complete package for:

  • Drug Master File: 98.7%
  • Letter of Access: 99.5%
  • Biannual Update: 99.6%

Drug Submission Evaluation Fees (Pharmaceuticals & Biologic Products)

Review 1 (average time in calendar days)Footnote **

Pharmaceuticals

  • NAS: NDS = 300
  • CLIN C&M: NDS = 300
  • CLIN C&M: SNDS = 300
  • CLIN : NDS = 300
  • CLIN: SNDS = 300
  • CLIN: DIN A = 210
  • COMP C&M: ANDS = 180
  • COMP C&M: NDS = 180
  • COMP C&M: SANDS = 180
  • COMP C&M: SNDS = 180
  • COMP C&M: DIN A = 210
  • C&M: ANDS = 180
  • C&M: NDS = 180
  • C&M: SANDS = 180
  • C&M: SNDS = 180
  • C&M: DIN A = 210
  • PUBLISHED DATA: SNDS = 300
  • PUBLISHED DATA: DIN A = 210
  • Rx to OTC Switch: SNDS = 180
  • DISINFECTANT: NDS-D = 300
  • DISINFECTANT: SNDS-D = 300
  • DISINFECTANT: DIN D = 210
  • DISINFECTANT: DIN D = 180
  • LABELLING ONLY : NDS = 60
  • LABELLING ONLY : SNDS = 60
  • LABELLING ONLY : ANDS = 60
  • LABELLING ONLY : SANDS = 60
  • LABELLING ONLY : DIN A = 180
  • LABEL STANDARD: DIN A = 45
  • LABEL STANDARD: DIN D = 45
  • LABEL STANDARD: DIN F = 45
  • ADMINISTRATIVE: ANDS = 45
  • ADMINISTRATIVE: NDS = 45
  • ADMINISTRATIVE: SNDS = 45
  • ADMINISTRATIVE: SANDS = 45
  • ADMINISTRATIVE: DIN A = 45
  • ADMINISTRATIVE: DIN D = 45

Biologics

  • NAS: NDS = 300
  • CLIN C&M: NDS = 300
  • CLIN C&M: SNDS = 300
  • CLIN C&M: DIN B = 210
  • CLIN: NDS = 300
  • CLIN: SNDS = 300
  • C&M: ANDS = 180
  • C&M: SANDS = 180
  • C&M: SNDS = 180
  • C&M: DINB = 210
  • COMP C&M: ANDS = 180
  • COMP C&M: SNDS = 180
  • LABELLING ONLY: SNDS = 60
  • PUBLISHED DATA: SNDS = 300
  • ADMINISTRATIVE: NDS = 45
  • ADMINISTRATIVE: DINB = 45

Review 1 (average time in calendar days)Footnote **

Pharmaceuticals

  • NAS: NDS = 257
  • CLIN C&M: NDS = 278
  • CLIN C&M: SNDS = 280
  • CLIN : NDS = N/A
  • CLIN: SNDS = 257
  • CLIN: DIN A = 208
  • COMP C&M: ANDS = 171
  • COMP C&M: NDS = 167
  • COMP C&M: SANDS = 168
  • COMP C&M: SNDS = 155
  • COMP C&M: DIN A = 178
  • C&M: ANDS = 173
  • C&M: NDS = 161
  • C&M: SANDS = 151
  • C&M: SNDS = 161
  • C&M: DIN A = 168
  • PUBLISHED DATA: SNDS = 230
  • PUBLISHED DATA: DIN A = N/A
  • Rx to OTC Switch: SNDS = 161
  • DISINFECTANT: NDS-D = 299
  • DISINFECTANT: SNDS-D = N/A
  • DISINFECTANT: DIN D = 196
  • DISINFECTANT: DIN D = N/A
  • LABELLING ONLY : NDS = 52
  • LABELLING ONLY : SNDS = 51
  • LABELLING ONLY : ANDS = 47
  • LABELLING ONLY : SANDS = 33
  • LABELLING ONLY : DIN A = 159
  • LABEL STANDARD: DIN A = 32
  • LABEL STANDARD: DIN D = 39
  • LABEL STANDARD: DIN F = 24
  • ADMINISTRATIVE: ANDS = 34
  • ADMINISTRATIVE: NDS = 33
  • ADMINISTRATIVE: SNDS = 25
  • ADMINISTRATIVE: SANDS = 32
  • ADMINISTRATIVE: DIN A = 13
  • ADMINISTRATIVE: DIN D = 33

Biologics

  • NAS: NDS = 270
  • CLIN C&M: NDS = 268
  • CLIN C&M: SNDS = 289
  • CLIN C&M: DIN B = 210
  • CLIN: NDS = N/A
  • CLIN: SNDS = 268
  • C&M ANDS = 180
  • C&M: SANDS = 180
  • C&M: SNDS = 160
  • C&M: DINB = 210
  • COMP C&M: ANDS = 178
  • COMP C&M: SNDS = 188
  • LABELLING ONLY: SNDS = 51
  • PUBLISHED DATA: SNDS = 242
  • ADMINISTRATIVE: NDS = 40
  • ADMINISTRATIVE: DINB = 45

Medical Device Licence Application Fees

Review 1 (average time in calendar days)Footnote **

  • Class II New = 15
  • Class III New = 60
  • Class III Near Patient = 60
  • Class III Manufacturing Amendment = 60
  • Class III Significant Amendment = 60
  • Class IV New = 75
  • Class IV Human-Animal Tissue = 75
  • Class IV Manufacturing Amendment = 75
  • Class IV Significant Amendment = 75

Review 1 (average time in calendar days)Footnote **

  • Class II New = 9
  • Class III New = 55
  • Class III Near Patient = 53
  • Class III Manufacturing Amendment = 50
  • Class III Significant Amendment = 54
  • Class IV New = 70
  • Class IV Human-Animal Tissue = 45
  • Class IV Manufacturing Amendment = 54
  • Class IV Significant Amendment = 64
 

Fees for Right to Sell a Licensed Medical Device

20 calendar days from deadline for receipt of annual notification to update the Medical Devices Active License Listing database

100% within 20 calendar days

Medical Device Establishment Licensing Fees

120 calendar days to issue / renew licence

Average number of days: 53.

Veterinary Drug Evaluation Fees

Review 1 (average time in calendar days)

  • NDS (including Priority Review) = 300
  • ANDS = 300
  • SNDS = 240
  • SANDS = 240
  • Admin = 90
  • DIN (including changes to DINs) = 120
  • NC = 90
  • ESC = 60
  • Labels = 45
  • Emergency Drug Release = 2

Review 1 (average time in calendar days)

  • NDS (including Priority Review) = 375
  • ANDS = 348
  • SNDS = 214
  • SANDS = N/A
  • Admin = 60
  • DIN (including changes to DINs) = 107
  • NC = 65
  • ESC = 45
  • Labels = N/A
  • Emergency Drug Release = <2

Veterinary Drugs fees have not been updated since 1995. As such, they are not subject to the User Fees Act. During the 2014-15 year, there were no consultations on the fees related to Veterinary Drugs. However, should there be any changes proposed, stakeholders will be consulted.

Service standards have been in place for VDD activities since 2007 and have been published on the departmental web site as part of the Guidance to Industry for the Management of Regulatory Submissions.

Fees Charged for filing a claim under the Hazardous Material Information Reviews Act

All claims registered within seven days of receipt of the completed application package.

77% of claims were registered within seven days of receipt of the complete application package.

(The 77% is not subject to the User Fees Act and penalties since the fees have not been updated since the User Fees Act came into force).

A consultation paper was sent to external stakeholders (User Fees) in February 2014. The document was a broader piece seeking input on the entire process, but included on the reported service standard of seven days to register a claim. No feedback was received from stakeholders on the registration service standard.

The next consultation on service standards will be held in 2016-17.

National Dosimetry Services Product (NDSP), Service and Fee Structure (S&F)

Provided timely, responsive and reliable costumer service to 95,000 workers in 12,500 Groups (Customers)

  1. Exposure reported within regulatory limits of 45 days from receipt.
  2. Dosimeters shipped 10-13 working days prior to exchange date to clients.
  3. Dose results for whole body and extremity services sent out within 10 days of dosimeter receipt.

Provided timely, accurate and reliable costumer service to 12,521 Groups (Customers):

  1. National Dosimetry Services (NDS) reported over 540,497 dosimeter readings to client groups with 100% compliance to the 45 day reporting limit.
  2. NDS shipped out 95% of dosimeters 10-13 working days prior to exchange date.
  3. NDS processed and reported over 540,497 readings with 91% reported within 10 days of dosimeter receipt.

NDS maintained regular contact with Clients through its Call Centre. As well, selected clients were contacted to participate in satisfaction questionnaires or in exit questionnaires when they departed.

Improvements implemented in 2014-15:

  1. NDS started using an improved phone technology system (EPAS) in April 2014.
  2. Selected clients using the Thermoluminescent Dosimeter (TLD) service were transitioned to the next generation TLD.

Improvements expected in 2014-15:

  1. NDS is finalizing improvements in the automated handling of the InLight dosimetry service.
  2. First transition of selected clients current on manual InLight expected to transition to the automated InLight service for Sept 1 (Q2).

Fees to be paid for Pest Control Product Application Examination Service

The performance Standard is 90% of submissions to be processed within the applicable review timelines.

Pest Management Regulatory Agency Service Standards:

  • Category A: Review timelines range from 285 to 655 days.
  • Category B: Review timelines range from 158 to 470 days.
  • Category C: Review timelines is 240 days.
  • Category D: Review timelines range from 10 to 247 days.
  • Category E: Review timelines range from 30 to 159 days.
  • Category A: 97%
  • Category B: 96%
  • Category C: 92%
  • Category D: 94%
  • Category E: 57%
    (The 57% is not subject to the User Fees Act and penalties since the fees have not been updated since the User Fees Act came into force.)

A consultation document reflecting early stakeholder feedback on proposed fees and related service standards was published on the Health Canada website on March 14, 2014.

As part of the User Fee requirements, a pre-proposal notification was published on the Health Canada internet for consultation on December 12, 2014.

Fees to be paid for the right or privilege to manufacture or sell a pest control product in Canada and for establishing a Maximum Residue Limit in relation to a pest control product

Target is for 100% of all fees to manufacture or sell a pest control product in Canada are invoiced by April 30th of each fiscal year.

100% of all invoices were issued by April 30, 2015.

(Not subject to Use Fees Act since the fees have not been updated since the Use Fees Act came into force.)

A consultation document reflecting early stakeholder feedback on proposed fees and related service standards was published on the Health Canada website on March 14, 2014.

As part of the User Fee requirements, a pre-proposal notification was published on the Health Canada internet for consultation on December 12, 2014.

Fees to be paid for the right of Employee Assistance Services (EAS)

(Fees are charged through contractual or formally-based agreements between Health Canada and other departments, agencies and federally-regulated organizations.)

Customers are billed by means of Journal Voucher, IS transactions, invoice and cheques, etc.

Services provided for fees includes:

  • Employee Assistance Programs (EAP)
  • Specialized Organizational Services (SOS)

N.B. The fees are not external but internal to federal government departments and agencies that transfer funds to Health Canada in exchange for the services listed above. The fees are aligned with the overall costs of delivering the services including oversight, quality management, outsourcing, invoicing processing, financial and business processes, auditing of files, training of staff, in accordance to accreditation standards, and departmental support as well as accommodation costs. EAS aims at being 100% cost recovery. No individual client or Canadian is being charged for these services.

As per formal agreement, varies depending on customer organization's requirements, needs and EAS capacity to meet service levels.

Service Standards include:

  • Less than 5% of incoming to the Crisis and Referral Centre calls go to voicemail.
  • First contact between mental health professional and client is 48 hours.
  • First appointment within three to five business days.
  • Client receives follow-up from counsellor two to three weeks after the last session.
  • Helping 70% of clients achieve problem resolution within EAS short term counselling model.

As per results from customer surveys, client satisfaction surveys, Bell telephone reports, and data collected from affiliate mental health professionals, EAS is meeting all of the service standards outlined in the contractual agreements.

  • Current call volume that are directed to voicemail or choosing the option to hold the line to maintain call priority is less than 5%. Actual rate for 2014-15 indicates that clients were greeted by a live voice is over 95% of calls.
  • First contact between client and councillor within 48 hours of original call is occurring over 95% of cases. Actual rate for 2014-15 was 99.7%.
  • The Quality Assurance periodic check indicates that 78% of the counsellors are in compliance with our requirements. Letters are sent to non-compliers and they are re-assessed in the next fiscal period.
  • First appointment within five business days is occurring in over 96% of cases.
  • The number of clients who received their follow-up from their counsellor in 2013-14 was 36.5%. This statistic is somewhat skewed as there are cases when clients request that the counsellor not follow-up with them, some clients may not have completed their counselling sessions when the survey was conducted.
  • EAS is helping clients achieve problem resolution without outside referral in 95% of cases.
  1. Customers:

    Federal departments and agencies comprise the majority of EAS' customer base, and they are consulted on a regular basis. Utilization data is provided at least annually to each customer organization. Formal agreements to renew contractual or ILA/MOU-type agreements are completed every one, two or three years. Customers are formally surveyed every two years, but contacts are communicated with regularly to ensure satisfaction and build customer relations.

  2. Clients:

    EAS is the largest provider of EAP to the public sector. EAS handled more than 15,000 cases last fiscal cycle, and provided over 45,000 hours of counselling sessions.

    Client satisfaction is one of the most key indicators of service quality. For each service delivered, clients are informed that their feedback regarding service quality is valuable and appreciated.

  3. Affiliates:

    EAS's network of more than 800 affiliates ensures that EAS has the capacity to offer services across Canada within industry-standard timeframes. This network covers Canada from coast to coast; it forms an invaluable source of feedback regarding service provision with respect to the client base at large.

  4. Legislating/Regulating Bodies:

    As a government entity, many of EAS practices and procedures regarding finance, human resources and operational management are prescribed by specific policies, regulations and/or laws. As such, EAS is accountable to these rules and must, at regular intervals, report on: the usage of funds; adherence to key legislation, such as Official Languages, Financial Administration Act, and Privacy Act.

  5. Staff:

    etention of knowledgeable and experienced staff has become a recognized problem in much of the federal public service. EAS, however, has consistently demonstrated a significantly higher level of staff retention when compared with the department as a whole.

Table footnotes

Footnote *

Denotes Fees Set by Contract (not subject to User Fees Act).

Return to footnote * referrer

Footnote **

Review 1 = the period from the date of acceptance for review to the first issuance of a decision.

Return to footnote ** referrer

Notes:

  1. Acronyms
    NDS:
    New Drug Submission
    SNDS:
    Supplement to a New Drug Submission
    ANDS:
    Abbreviated New Drug Submission
    SANDS:
    Supplement to an Abbreviated New Drug Submission
    DIN:
    Drug Identification Number
    • DIN A drug identification number application for a pharmaceutical
    • DIN B drug identification number application for a biological
    • DIN D drug identification number application for a disinfectant
    • DIN F drug identification number application for a Category IV Monograph
    ESC:
    Experimental Studies Certificate
    INDS:
    Investigational New Drug Submission
    N/A:
    At time of reporting either no submissions of that type were received or no reviews of that submission type were completed, therefore no performance information available.
    NAS:
    New Active Substance
    NC:
    Notifiable Change
    NDS:
    New Drug Submission
    OTC:
    Over the Counter
    Rx:
    Prescription
    SANDS:
    Supplement to an Abbreviated New Drug Submission
    SNDS:
    Supplement to a New Drug Submission
  2. Performance

    As per the User Fee Act (UFA), when Where a regulating authority's performance in a particular fiscal year in respect of a user fee does not meet the standards established by it for that fiscal year by a percentage greater than ten per cent, the User Fee Act requires that the user fee be reduced by the percentage missed, up to a maximum of 50%. The reduced fees are in effect until the date of the next Departmental Performance Report.

    One Biologics Drug Evaluation fee line did not meet the performance standard, but did not exceed the target by more than 10%, so there are no penalties incurred. They are: COMPARATIVE STUDIES C&M/ SNDS, with a target of 180 days, and a performance of 188 days.

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